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Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis, Utilisation of Health Care Resources in Patients With COPD (COSYCONET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hannover Medical School
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Claus Vogelmeier, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT01245933
First received: November 18, 2010
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the prevalence and severity of extrapulmonary disorders and to quantify the impact of extrapulmonary organ manifestations on morbidity and mortality of COPD patients.

Furthermore the investigators evaluate the relationship between systemic inflammation and organ involvement.


Condition
Chronic Obstructive Pulmonary Disease (COPD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Systemic Manifestations/Comorbidities on Clinical State, Prognosis and Utilisation of Health Care Resources in Patients With COPD

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Change from baseline in BODE-Score at 18 months [ Time Frame: at initial visite, after 18 month ] [ Designated as safety issue: No ]
    The BODE-Score comprises BMI, airway obstruction, dyspnea and exercise capacity and is a good predictor for death in COPD patients. Progression is defined as a change in BODE-score by >=1 point over the observation period.


Secondary Outcome Measures:
  • COPD related mortality [ Time Frame: after 18 months ] [ Designated as safety issue: No ]
  • COPD related hospitalization [ Time Frame: after 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood urine


Estimated Enrollment: 3000
Study Start Date: November 2010
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Chronic diseases and comorbidities have an increasing impact on individual life and health care use, as exemplified in chronic obstructive pulmonary disease (COPD). Currently, independent, comprehensive databases allowing for an integrated view are lacking. The study will for the first time establish a large, comprehensive longitudinal database covering a broad panel of comorbidities an markers of systemic alterations. These data will be of unique value in revealing specific phenotypes of COPD via patterns and risk profiles of comorbidities, enabling a more precise diagnosis and targeting of therapy, and an efficient allocation of resources.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Since the original recruitment strategy was not as successful as expected,the mode of recruitment was extended to other physicians, patients' groups and organisations and advertising to local media. The recruitment is supported by professional measures of communication organized by the coordinating centre Marburg.

Criteria

Inclusion Criteria:

  • aged 40 years and older
  • diagnosis of COPD (GOLD-Criteria)
  • informed consent
  • available for repeated study visits pver 18 months

Exclusion Criteria:

  • having undergone big lung surgery (e.g. lung reduction, lung transplant)
  • Moderate or severe exacerbation within the last 4 weeks
  • having a lung tumor
  • Unable to walk or to understand the intention of the project
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245933

Locations
Germany
Kreisklinik Bad Reichenhall, Zentrum für Innere Medizin-Lungenzentrum
Bad Reichenhall, Germany, 83435
Ev. Lungenklinik (ELK), Krankenhausbetriebs gGmbH, Pneumologische Klinik
Berlin, Germany, 13125
BG-Universitätskliniken Bergmannsheil GmbH, Medical Clinic
Bochum, Germany, 44789
Forschungszentrum Borstel, Medizinische Klinik
Borstel, Germany, 23845
Krankenhaus Lindenbrunn
Coppenbrügge, Germany, 31863
Krankenhaus Coswig
Coswig, Germany, 01640
Klinik Donaustauf, Zentrum für Pneumologie
Donaustauf, Germany, 93093
Ruhrlandklinik Essen, Westdeutsches Lungenzentrum
Essen, Germany, 45239
EvA-Study Center, Helholtz Zentrum München
Gauting, Germany, 82131
Justus-Liebig-Universität, Medizinische Klinik II
Gießen, Germany
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität, Zentrum für Innere Medizin
Greifswald, Germany, 17475
Krankenhaus Großhansdorf, Pneumologisches Forschungsinstitut
Großhansdorf, Germany, 22927
HIT-Hamburger Institut für Therapieforschung GmbH
Hamburg, Germany, 20354
Medical School Hannover, Dep. of Pneumology
Hannover, Germany, 30625
Universitätsklinik Heidelberg
Heidelberg, Germany, 69120
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
University of Saarland
Homburg, Germany, 66421
Fachklinik für Lungenerkrankungen Philippsstiftung ev.
Immenhausen, Germany, 34376
Universitiy of Kiel
Kiel, Germany, 24105
Universitätsklinikum Leipzig, Department Innere Medizin
Leipzig, Germany, 04103
Klinik Löwenstein
Löwenstein, Germany, 74245
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz K. d. ö. R.
Mainz, Germany, 55131
Philipps-University Marburg, Medical Center, Dep. of Pneumology
Marburg, Germany, 35042
Ludwig-Maximilians-University, Medizinische Klinik Innenstadt
Munic, Germany, 80336
Klinikum Nürnberg, Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie und Schlafmedizin
Nürnberg, Germany, 90419
Universitätsklinikum Rostock, Zentrum für Innere Medizin, Abt. f. Pneumologie
Rostock, Germany, 18057
Klinikum Berchtesgardener Land, Schön Kliniken, Fachzentrum für Pneumologie, Allergologie und Schlafmedizin
Schönau am Königssee, Germany, 83471
Krankenhaus Bethanien gGmbH
Solingen, Germany, 42699
University of Ulm
Ulm, Germany, 89081
Missionsärztliche Klinik GmbH, Innere Medizin
Würzburg, Germany, 97067
Sponsors and Collaborators
Philipps University Marburg Medical Center
Hannover Medical School
Ludwig-Maximilians - University of Munich
Investigators
Study Chair: Claus Vogelmeier, Prof. Philipps University Marburg Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Claus Vogelmeier, Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT01245933     History of Changes
Other Study ID Numbers: 01GI0881
Study First Received: November 18, 2010
Last Updated: June 17, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
COPD
register
comorbidities
systemic inflammation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014